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Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee

February 20, 2008

Briefing Information

Topic 1

Sponsor

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

GlaxoSmithKline Biologicals Briefing Document (pdf)

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

 
FDA Briefing Document, FDA Statistical Review and Evaluation; Rotarix, Live Attenuated Human Rotavirus (HRV) Vaccine, Oral (GSK) (html)

FDA Briefing Document, Rotarix (rotavirus vaccine, live, oral) (html)

Errata FDA Briefing Document, Rotarix (rotavirus vaccine, live, oral) (doc) (html)

Page last updated February 15, 2008 kkhorizonal rule
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